Prevention of HIV in "Île-de-France" (ANRS-PREVENIR)

  • STATUS
    Recruiting
  • End date
    Oct 13, 2024
  • participants needed
    3257
  • sponsor
    ANRS, Emerging Infectious Diseases
Updated on 13 June 2022
antiretroviral
antiretroviral agents
hiv test
pre-exposure prophylaxis (prep)
hepatitis
truvada
post-exposure prophylaxis
enzyme-linked immunosorbent assay
gonorrhea
hiv-1 infection
venereal disease
Accepts healthy volunteers

Summary

Interventional HIV prevention strategy based on pre-exposure prophylaxis (PrEP) with Truvada® for people in the Île-de-France area (or Paris region) who don't have HIV but who are at high risk of becoming infected with HIV (men who have sex with men (MSM), transgender men and women, heterosexual men and women, sex workers, migrants) in combination with overall prevention services (communautary-based or educational counselling; addiction, social and psychological care; condoms and lubricating gel; clean injection equipment; sexually transmitted diseases (STD) screening and treatment; hepatitis A virus (HAV), hepatitis B virus (HBV) and hepatitis C virus (HCV) vaccinations and post-exposure treatment of HIV infection as soon as possible after diagnosis using an antiretroviral combination recommended by the French Guidelines on HIV treatment).

The individual benefit being already demonstrated in clinical trials, the aim is to demonstrate the public health impact of the interventional HIV prevention strategy by reducing the risk of getting HIV-1 infection of at least 15% of new diagnosis of HIV infections among MSM/transgender in the Ile-de-France area after a 3-year period.

Description

Assuming the PrEP efficacy of 80% and that 85% of included participants being MSM - the objective is to evidence a decrease of at least 15% of new diagnosis of HIV infections among MSM in Ile-de-France area. This objective is in the framework of a commitment of large cities against AIDS with the political support of the City of Paris for the "Paris sans SIDA" program and the commitment of the Île-de-France area.

Secondary Objectives:

  • Prevalence of HIV infection at the screening visit (undiagnosed epidemic)
  • Incidence of HIV infection according to back-calculation approach, and by key subgroups

Operational Objectives:

  • Evaluate the origin of the recruitment according to the risk groups and the outreach actions
  • Assess linkage to care for PrEP, retention in the study, reasons for consent withdrawal and satisfaction of the participants according to the screening site, the type of PrEP supply, the costs of global care, the key subgroups, the type of counselling, the time from STD testing to initiation of PrEP treatment in study sites
  • Impact of a less intense counselling than the one provided in the ANRS IPERGAY trial, on adherence and efficacy of PrEP by comparing the incidence observed in MSM enrolled in the current study to that evidenced in the ANRS IPERGAY trial, with a method similar to that used in the Partner demonstration project in Kenya and Uganda.
  • Impact of the communautary-based and educational counselling

Clinical Objectives:

  • Estimation, in individuals seeking for PrEP and thus getting tested for HIV infection, the prevalence of HIV infection in different key subgroups, which is a surrogate marker of the undiagnosed (or "hidden") epidemic
  • Evaluate who will become HIV-infected during the course of the study while on PrEP, the proportion of patients on combined antiretroviral treatment and the proposition of patients with a suppressed HIV viral load 12 months after HIV infection
  • Evaluate the participants' need for post-exposure prophylaxis during the course of the study
  • Adherence to PrEP (questionnaire and dried blood spots)
  • Assessment of the PrEP dosing schedule used by MSM participants (daily or intermittent) throughout the course of the study
  • Assessment of PrEP tolerability and safety
  • Comprehensive study of incident HIV infections in those on PrEP (incidence, emergence of drug-associated resistance mutations, adherence to PrEP at the closest visit before HIV seroconversion and at previous visits)

Participants Behavior:

  • Acceptability of PrEP (including those who will decline participation in the study) and during the course of the study, and retention in the study.
  • Impact of PrEP, within a comprehensive prevention offer, on sexual behavior of the participants throughout follow-up
  • Factors associated with the integration of PrEP in the daily routine of participants:
  • Qualitative study to explore the motivations, difficulties, behavior and expectations of the participants, their knowledge and communication on their use of PrEP
  • Reasons related to the choice of the prevention strategy used in terms of dosing schedule (continuous or on demand in MSM) and type of counselling and participation to focus groups.

Care Providers Behavior: Evaluation of knowledge, beliefs, perception and practice of the physicians, nurse and peer counselors involved in delivery of PrEP in the study

Social epidemiology: Evaluation of social and/or territorial inequalities and disparities

Cost-effectiveness of the comprehensive prevention strategy

Details
Condition HIV Infections
Treatment PrEP with Truvada®
Clinical Study IdentifierNCT03113123
SponsorANRS, Emerging Infectious Diseases
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Men/transgender men/women who have sex with men, heterosexual men and women, sex workers
Negative for HIV-1 and HIV-2 (with a fourth generation enzyme-linked immunosorbent assay (ELISA) assay)
Willing the geocoding of the postal address and to be contacted via telephone or email, on a regular basis
Willing to comply to visits schedule (every 3 months)
Health security program
Informed consent form signed
High risk of acquiring HIV infection
For MSM and transgenders
Anal sex with at least two different sexual partners and no consistent condom use over the last 6 months
And/or history of STD during the last 12 months (syphilis, gonorrhea , chlamydiae, HBV or HCV infection)
And/or history of non-occupational post-exposure prophylaxis (PEP) during the last 12 months
And/or using psycho-actives drugs during sexual intercourses (cocaine, gammahydroxybutyric acid (GHB), Methylenedioxymethamphetamine (MDMA), mephedrone)
And/or having an HIV-infected sexual partner with a detectable plasma viral load (> 50 copies (cp)/milliliter (ml))
For heterosexual
Sexual intercourse with 1 partner originating from regions with high prevalence of HIV infection (> 1%) (South America, Sub-Saharan Africa, South-East Asia, Eastern Europe, French Guyana) and no consistent condom use
and/or sex workers
and/or having a sexual partner who is an intravenous drug users sharing injection material
and/or having an HIV-infected sexual partner with a detectable plasma viral load (> 50 cp/ml)

Exclusion Criteria

Stable and exclusive relationship with an HIV-negative partner, or with an HIV-positive partner on antiretroviral therapy (ART) with a plasma viral load < 50 cp/ml
Positive HIV infection
Clinical signs of positive HIV infection
Consistent condom use during sexual intercourse
Expected trip abroad for 3 consecutive months
Creatinine clearance lower than 50ml/min
History of chronic renal disease, osteoporosis or osteopenia
Receiving an investigational drug
Receiving or will receive potentially nephrotoxic treatments
Gastro-intestinal condition that could limit drug absorption
Potentially non compliant participants
Breastfeeding
Hypersensitivity to TDF/FTC
Positive HBs antigen or isolated anti hepatitis B core (HBc) antibodies if not willing to take daily PrEP
Severe condition (lymphoma, other cancers, cardio-vascular disease, end-stage renal failure, uncontrolled diabetes)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note